Kornimate/medical-research-clean huggingface dataset:
compassionate use of ibalizumab for the treatment of hiv infection

Conditions: Human Immunodeficiency Virus (HIV)

Summary: ibalizumab is a humanized immunoglobulin g monoclonal antibody directed against a human t-cell receptor (cd4) and thus suppresses hiv replication by blocking entry of hiv into cd4+ lymphocytes. ibalizumab has completed phase i and ii clinical studies in hiv-negative and hiv-infected individuals showing safety and efficacy for suppressing hiv replication.

1. ibalizumab is a humanized immunoglobulin g monoclonal antibody directed against a human t-cell receptor (cd4) and thus suppresses hiv replication by blocking entry of hiv into cd4+ lymphocytes. ibalizumab is in the pipeline for fda approval to treat hiv infection. phase i and ii clinical studies have been completed in hiv-negative and hiv-infected individuals showing safety and efficacy for suppressing hiv replication. 2. use of this medication requires that a single patient ind be obtained from the fda for each patient requiring ibalizumab. an individual use ind has been approved by the fda for one patient on treatment through this protocol; the ind number is 114515. the manufacturer of ibalizumab (taimed biologics, inc) will ship the drug directly to the denver health pharmacy.

Eligibility criteria:
inclusion criteria: * adult patients with a diagnosis of hiv-infection with resistance or intolerance to currently available antiretroviral medications available in the united states or in whom additional drugs need to be added to their regimen because of inadequate response to existing therapy * patients with hiv infection that is expected to be sensitive to dolutegravir and ibalizumab * patients who do not qualify for or who are otherwise ineligible for clinical trials of medications not currently approved for treatment of hiv infection in the u.s. exclusion criteria: * patients who are allergic to or have had a severe adverse reaction to dolutegravir or ibalizumab in the past. * age \ 89 years * women may not be pregnant * prisoners and decisionally challenged patients will be excluded
inhibition control of children and adolescents with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the objectives of this study are to investigate: 1. the effect of methylphenidate on attention; 2. the relations between methylphenidate and inhibition control and working memory; 3. the relations between inhibition control and verbal attention and working memory; 4. the effect of methylphenidate on the changes of neuropsychological functioning and blood pressure.

attention deficit hyperactivity disorder (adhd), characterized by inattention, hyperactivity and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies. it affects 5-10% of school-aged children worldwide (7.5% in taiwan). methylphenidate, a stimulant, is effective in treating these patients. studies in taiwan show no effect of methylphenidate on blood pressure. there are evidences show that the change of blood pressure was associated with inhibition of impulsive behaviors. stop signal task(sst) is used to assess the improve of inhibition control after methylphenidate response. by using repeated outcome measurements, we anticipate that this study will evaluate the improvement of neuropsychological performances after medication and determinie the association between medication response and neuropsychological functions and vital signs in a taiwanese sample.

Eligibility criteria:
inclusion criteria: the inclusion criteria for the subjects are (1)that subjects have a clinical diagnosis of adhd defined by the dsm-iv which was made by a full-time board-certificated child psychiatrist; (2)their ages range from 10 to 18 when we conduct the study; (3)their iq greater than 80; and (4)they are under treatment of methylphenidate. exclusion criteria: the subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by dsm-iv: schizophrenia, schizoaffective disorder, organic psychosis, or pervasive developmental disorder.
integrated molecular and clinical profiling to optimize outcome prediction in splenic marginal zone lymphoma

Conditions: Splenic Marginal Zone Lymphoma

Summary: the study aims at developing and validating an integrated clinico-molecular model for an accurate survival prognostication in newly diagnosed smzl. already existing and coded tumor biological material and health-related personal data will be retrospectively collected. mutation analysis will be performed by targeted deep next generation sequencing of tumor genomic dna. deletion of 7q will be assessed by fish on nuclei isolated from tumor tissues. immunoglobulin gene rearrangement and mutation status will be analyzed on tumor genomic dna by pcr and sanger sequencing. the methylation status of target genes will be assessed by methylation specific pcr on tumor genomic dna. the adjusted association between exposure variables and os will be estimated by cox regression. this approach will provide the covariates independently associated with os that will be utilized in the development of a hierarchical molecular model to predict os. the hierarchical order of relevance in predicting os among covariates will be established by recursive partitioning analysis. an amalgamation algorithm will be used to merge terminal nodes showing homogenous os. the discrimination capacity of the model will be assessed by calculating the c-index. relative survival analysis will be used to provide a measure of the excess mortality experienced by patient's subgroups stratified according to the developed hierarchical molecular models, irrespective of whether the excess mortality is directly or indirectly attributable to the disease. the model developed in the training set will be tested in the validation sets and the model performance (c-index) in the validation set will be compared with that in the training set.


Eligibility criteria:
inclusion criteria: * male or female adults 18 years or older * diagnosis of smzl on spleen histology before dec 31st 2010 (to provide the cohort with a minimum follow-up of at least 5 years) * availability of tumor material (from spleen, peripheral blood or bone marrow) collected before initiation of medical therapy * availability of the baseline and follow-up annotations exclusion criteria: * having received any medical therapy including anti cd20 monoclonal antibody, chemotherapy or biological agents before splenectomy
hepatocellular carcinoma imaging using psma pet/ct

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the research is to evaluate the use of a psma pet/ct (prostate specific membrane antigen positron emission tomography/computerized tomography) scan in the diagnosis of hcc (hepatocellular carcinoma) and comparing it to standard scanning techniques with ct (computed tomography) or mri (magnetic resonance imaging).

a total of 30 patients will be recruited in this prospective pilot study who have hcc on imaging criteria (li-rads 5) for surgical resection, or patients with indeterminate liver lesions (li-rads 3 or 4) planned for liver biopsy. 18f-dcfpyl psma pet/ct will be performed prior to the planned surgery or liver biopsy

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or older at screening * has provided written informed consent for participation in the study * must have risk factors for hcc e.g. cirrhosis, chronic hepatitis b infection with or without cirrhosis * patients with liver lesions ≥1 cm suspicious for hcc but with indeterminate features on ct and mri meeting li-rads 3 or 4 criteria planned for biopsy, or patients with liver lesions diagnostic of hcc based on ct or mri meeting li-rads 5 criteria planned for surgical resection * patients must be willing and able to comply with the protocol and procedures for the duration of the study * patients must be available for follow-up exclusion criteria: * abdominal surgery or radiotherapy to the abdomen within \<4 weeks of registration. patients must have recovered from any effects of any major surgery * uncontrolled intercurrent illness that is likely to impede participation and or compliance * any history of prostate cancer or elevated psa level for male patients * other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ * participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks * has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study * women who are pregnant or lactating * cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. budd-chiari syndrome) or cardiac cirrhosis

Keywords: hepatocellular carcinoma psma 18f-dcfpyl
recurrence post-transplant observational study in focal segmental glomerulosclerosis and minimal change disease

Conditions: Focal Segmental Glomerulosclerosis; Minimal Change Disease; FSGS; MCD

Summary: the morbidity of recurrence of focal segmental glomerulosclerosis (fsgs) and minimal change disease (mcd) after transplant is well-recognized and include contemporary reduction in quality of life, edema, early graft loss and mortality. efforts to understand its mechanisms and improve its treatment have been limited by small sample sizes in single center studies and misclassification in registry studies. recent advances in the understanding of the mechanisms of fsgs in the native kidney has reinvigorated the scientific community to develop a collaborative community to advance research into the epidemiology, mechanisms, interventions, and outcomes. the purpose of resolve is to gather a group of people with fsgs and mcd that have had or will have a kidney transplant to create a bank of information and biospecimens so researchers can more effectively study these diseases.

resolve is a multicenter, observational cohort study to examine the post-transplant course of patients with fsgs and mcd across the lifespan. the study is designed to collect both retrospective and prospective data as well as biospecimens and patient reported information. with multiple enrollment options, the study will allow investigators to define the incidence and prevalence of fsgs recurrence, describe the post-transplant course of patients with fsgs and mcd across the lifespan, and develop a biorepository to support future translational research studies to explore relevant disease mechanisms.

Eligibility criteria:
inclusion criteria: * retrospective non-consented participant group had a transplant from the year 2000 and onward. * diagnosis of fsgs or mcd in the native kidney (prior to transplant). exclusion criteria: * pathologic diagnosis other than fsgs or mcd * fsgs or mcd secondary to a known disorder (e.g. lupus nephritis, immunoglobulin a (iga) nephropathy, malignancy)

Keywords: kidney disease kidney transplant adult children recurrence
comparing adductor canal block and adductor canal block-local infiltration analgesia for post-operative pain management

Conditions: ACL Tear; ACL; ACL Injury

Summary: anterior cruciate ligament (acl) reconstruction is one of the most commonly performed surgeries amongst young orthopedic surgery patients. optimal post-operative pain control helps to reduce the opioid burden and to improve the patient's experience. regional anesthesia, such as the femoral nerve block (fnb) and adductor canal block (acb), are commonly used for post-operative pain control after surgery. the acb has replaced the fnb. this is because the acb targets the femoral nerve, while avoiding the numbing effects on quadricep muscle strength that make it difficult to move the leg. another form of pain control is local infiltration anesthesia (lia), which directly blocks pain in the knee. similar to the acb, it avoids the numbing effects on the quadricep muscle.this can help improve patient safety and experience by reducing risks of falls and allowing the patient to move earlier. this can also be associated with decreased time in the hospital and decreased costs. technically, it is less complex and can be done the shorter period of time. the purpose of this study is to refine the pain management technique following anterior cruciate ligament surgery. more specifically, the aim of this study is to evaluate the effects of lia alone, and a lia-acb combination on post-operative pain and thigh muscle strength.


Eligibility criteria:
inclusion criteria: * english speaking or any other language with possibility of adequate translation * asa i-iii patients * age 18-50 * bmi ≤ 38 kg/m2 exclusion criteria: * refusal or inability to provide informed consent * any contraindication to regional anesthesia including coagulopathy or bleeding diathesis, * allergy to local anesthetics, or infection at the site of the block * history of long-term opioid intake (more than 3 months use) or chronic pain disorder (more than 3 months) * history of preexisting neuropathy in the operative leg * revision of acl repair
cerebral oxygenation and neurological outcomes following critical illness-2

Conditions: Critical Illness; Respiratory Failure; Shock; Delirium

Summary: this study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. we use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. acute neurological dysfunction is defined as the presence of delirium, which is assessed using the confusion assessment method-intensive care unit (cam-icu). chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (kinarm robot) and traditional neuropsychological screening (repeatable battery for the assessment of neuropsychological status).


Eligibility criteria:
inclusion 1. adults ≥ 18 years old 2. admitted to a critical care unit requiring one or more of the following: (a) respiratory failure requiring invasive mechanical ventilation with an expected duration \>24 hours (b) shock of any etiology. shock is defined by the need for one of the following vasopressors/inotropes: (i) dopamine ≥7.5 mcg/kg/min (ii) dobutamine ≥5 mcg/kg/min (iii) norepinephrine ≥5 mcg/min (iv) phenylephrine ≥75 mcg/min (v) epinephrine at any dose (vi) milrinone at any dose (if used in conjunction with another agent) (vii) vasopressin ≥0.03 u/min(if used in conjunction with another agent) exclusion: 1. admission to the icu \> 24 hours 2. life expectancy \<24 hours 3. admitting diagnosis that affects the central nervous system 4. any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)

Keywords: cerebral oximetry near-infrared spectroscopy neurocognitive post-icu syndrome
sis evaluation of the mri defined subthalamic nucleus*

Conditions: Deep Brain Stimulation

Summary: retrospective review of images used to target the stn during dbs procedure and ability of the surgical information sciences ("sis") system to visualize the stn location.

the purpose of this study is to collect retrospective data to demonstrate the ability of the sis system to visualize the mri-defined stn in patients with parkinson's disease (pd) who have undergone deep brain stimulation (dbs) procedure targeting the stn.

Eligibility criteria:
key inclusion criteria: * idiopathic pd * bilateral or unilateral stn-hfs for pd * 40% improvement response to medications preoperatively key exclusion criteria: * missing required mr/ct imaging data

Keywords: stn parkinson's disease subthalamic nucleus
the effect of salmeterol on eosinophil (eos) function

Conditions: Allergic Asthma

Summary: this study is designed to test the hypothesis that salmeterol use, and not fluticasone use or the combination treatment with fluticasone and salmeterol, is associated with a greater number of sputum eosinophils following antigen challenge and, under these circumstances, the migrating peripheral blood eosinophils are less adherent.

an antigen challenge is when a participant inhales either cat, ragweed, or dust dander in increasing concentrations until their lung function drops 15 or 20 percent.

Eligibility criteria:
inclusion criteria: * 18-55 years of age * history of asthma symptoms for the previous 6 months * forced expiratory value (fev1) \>75% of predicted * positive prick skin test to cat, house dust mite or ragweed exclusion criteria: * history of life threatening asthma or anaphylaxis * current smoker * pregnant or breast-feeding * evidence of an upper respiratory infection within 4 weeks of screening
feasibility study to test clinical efficacy of low energy ac magnetic field to treat major depression

Conditions: Major Depressive Disorder (MDD)

Summary: this feasibility study investigates effects of eeg-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder.

major depressive disorder (mdd) is associated with functional impairment and disability, and results in a significant burden on the affected individual, his or her family, and society in general. psychopharmacological therapy has been shown to be effective, but may be accompanied by significant side effects. the investigators propose an alternative model, based on the relationship between symptoms, brain metabolism, and neural activity as recorded with electroencephalography (eeg). subjects with mdd often have decreased brain metabolism, accompanied by increased eeg activity in the alpha band. the investigators hypothesis is that a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which oscillates at precisely his or her intrinsic alpha frequency (iaf) can take advantage of this relationship to reduce symptoms without the significant side effects associated with pharmaceuticals. the investigators propose a 4-week, sham controlled, randomized, double-blind multi-center feasibility study to determine the efficacy of synchronized low energy magnetic fields delivered at the subject's iaf to treat mdd. treatment will be given concomitant to the subject's existing medication, and will occur 5 days per week at the clinical site. target enrollment is 45 adult subjects diagnosed with mdd.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * diagnosis of mdd with hamd-17 greater than or equal to 17 * on a stable dose of existing medication or no medication for 1 month or longer prior to the study exclusion criteria: * diagnosed with another primary axis i illness * recent history of or current substance abuse * clinically significant medical illness, including any thyroid disorders * known pregnancy and/or lactation, or intent to become pregnant during the study

Keywords: depression magnetic field alpha frequency eeg neosync eeg synchronization therapy
combined aphasia and robot-assisted arm treatment for chronic stroke survivors

Conditions: Stroke; Aphasia Following Cerebral Infarction; Hemiparesis After Stroke

Summary: the goal of this clinical trial is to learn if a program that combines language and arm treatment can improve language and movement problems in people with chronic stroke. the mains questions it aims to answer are: * to determine the extent to which this combined treatment can improve language. * to determine the extent to which the combined treatment can improve arm movements. researchers will compare the effects of this combined treatment with treatment that targets arm movements alone.


Eligibility criteria:
inclusion criteria: 1. male or female patients between 18-90 years of age. 2. right-handed prior to stroke 3. english-speaking (monolingual) 4. history of single left-hemisphere stroke at least 6 months prior to enrollment 5. presence of aphasia and naming deficits on western aphasia battery (wab-r) 6. comprehension score above 4 on wab-r 7. unilateral upper limb paresis (fugl-meyer upper extremity score \<56) 8. documentation of signed informed consent by the study participant. exclusion criteria: 1. diagnosis or history of speech impairment prior to stroke 2. severely limited speech output (score below 2 on spontaneous speech portion of wab-r) 3. inability to perform screening tasks due to severe language and/or cognitive impairment 4. condition limiting passive movement in the range of motion required for robotic therapy (e.g. fixed contracture) 5. any medical or psychiatric condition that may impact participation or compliance with study procedures or activities in the opinion of the investigator

Keywords: stroke, aphasia, hemiparesis, robotic
effects of pes planus on quality of life

Conditions: Pes Planus

Summary: this study will be conducted to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. in the study, various evaluations and questionnaires will be applied to the participants by dividing them into two groups by performing the navicular drop test. in the study, questionnaires and applications such as digital dynamometer measurements, foot function index (afi), international physical activity questionnaire (ipaq), 6 minute walk test, blood pressure, heart rate, saturation measurements, modified borg scale and sf-36 quality of life questionnaire will be used.

the aim of this study is to investigate the effect of pes planus on physical activity level, exercise capacity and quality of life in young adults. there are studies examining the effects of pes planus on physical fitness, quality of life, balance and pain levels. however, there are no studies evaluating the effect of pes planus on exercise capacity and physical activity level. it will enable us to have information about its capacity and its effect on quality of life and to obtain workable data. thanks to these data, the orientation towards treatment options for the negative effects of pes planus will increase. after the approval of the ethics committee, 32 participants who meet the inclusion criteria will be included in the study. the participants will be divided into two groups, 16 with pes planus and 16 without pes planus, by performing the navicular drop test. the foot muscle strength of the participants will be measured with a digital muscle strength device (lafayette manual muscle). the international physical activity questionnaire (ipaq) will be used for the physical activity level of the participants, the 6-minute walking test for the exercise capacity, the sf-36 quality of life questionnaire for the quality of life, and the foot function index (afi) for the foot functional status. heart rate, blood pressure, borg value and oxyhemoglobin value will be measured before and after the 6-minute walking test to be performed on the participants. according to these measurements, the physical activity levels, exercise capacities and quality of life of the participants in both groups will be compared.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-30, * being able to walk independently (can use a walking aid) * not having a diagnosed psychiatric disorder. exclusion criteria: * presence of inflammatory, systemic, degenerative and neurological diseases of the foot and ankle, * presence of standing equine, hallux valgus and hallux rigidus deformities * current history of surgery related to the foot-ankle, * existence of cooperation disorders that would prevent participation in the study.

Keywords: physical activity exercise capacity life quality